International Pharmaceutical Industry (IPI)
Spring / Summer 2013 Volume 5 Issue 2
Patients taking part in clinical trials may suffer from permanent or temporary harm as a result of their participation in the research. Research regulations worldwide aim to prevent research injuries as well as to provide remedies for injuries suffered by research participants, regardless of what or who may have caused those injuries. The ICHGCP guidelines mandate that sponsors make provisions for compensation for research-related injuries but largely leave compliance to applicable national or local regulatory requirements.
Though there is no dispute that remedial measures are required for research-related injuries, how patients are to be compensated is a hotly debated topic, and worldwide regulations differ considerably in this respect.